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Brentuximab Vedotin in Patients With CD30-positive Nonlymphomatous Malignancies

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01461538
First Posted: October 28, 2011
Last Update Posted: March 4, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Seattle Genetics, Inc.
  Purpose
This is an open-label, multicenter, phase 2 clinical trial to evaluate the antitumor activity of brentuximab vedotin as a single agent in patients with CD30-positive nonlymphomatous malignancies.

Condition Intervention Phase
Acute Lymphoid Leukemia Acute Myeloid Leukemia Anemia, Refractory, With Excess of Blasts Solid Tumors Drug: brentuximab vedotin Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Open-label Study of Brentuximab Vedotin in Patients With CD30-positive Nonlymphomatous Malignancies

Resource links provided by NLM:


Further study details as provided by Seattle Genetics, Inc.:

Primary Outcome Measures:
  • Objective Response Rate (ORR) by Investigator [ Time Frame: Up to approximately 3 years ]
    Percentage of participants who achieved a best response of complete response/remission (CR), CR without hematologic recovery (CRi; leukemia only), or partial remission (PR) per the applicable response criteria. Response criteria for solid tumors (by radiographic tumor imaging) per Response Evaluation Criteria for Solid Tumors (RECIST) 1.1 (Eisenhauer 2009); response criteria for leukemia (by peripheral blood and bone marrow aspirate or biopsy) per International Working Group (Cheson 2003).


Secondary Outcome Measures:
  • Complete Remission (CR) Rate by Investigator [ Time Frame: Up to approximately 3 years ]
    Percentage of participants who achieved a best response of CR per the applicable response criteria. Response criteria for solid tumors (by radiographic tumor imaging) per Response Evaluation Criteria for Solid Tumors (RECIST) 1.1 (Eisenhauer 2009); response criteria for leukemia (by peripheral blood and bone marrow aspirate or biopsy) per International Working Group (Cheson 2003).

  • Duration of Objective Response by Kaplan-Meier Analysis [ Time Frame: Up to approximately 2 years ]
    Duration of objective response (CR [+CRi; leukemia] + PR), defined as time of initial response until disease progression or death. Response criteria for solid tumors (by radiographic tumor imaging) per Response Evaluation Criteria for Solid Tumors (RECIST) 1.1 (Eisenhauer 2009); response criteria for leukemia (by peripheral blood and bone marrow aspirate or biopsy) per International Working Group (Cheson 2003).

  • Duration of Complete Response by Kaplan-Meier Analysis [ Time Frame: Up to approximately 2 years ]
    Duration of CR, defined as time of initial response until disease progression or death. Response criteria for solid tumors (by radiographic tumor imaging) per Response Evaluation Criteria for Solid Tumors (RECIST) 1.1 (Eisenhauer 2009); response criteria for leukemia (by peripheral blood and bone marrow aspirate or biopsy) per International Working Group (Cheson 2003).

  • Progression-Free Survival by Kaplan-Meier Analysis [ Time Frame: Up to approximately 2 years ]
    Progression-free survival, defined as time from start of study treatment to disease progression per investigator or death due to any cause

  • Adverse Events by Severity, Seriousness, and Relationship to Treatment [ Time Frame: Up to approximately 3 years ]
    Counts of participants who had treatment-emergent adverse events (TEAE, defined as newly occurring or worsening after first dose on Study SGN35-013). Serious adverse events are reported from the time of informed consent. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 4.03) were used to assess severity (1=mild, 2=moderate, 3=severe, 4=life-threatening/disabling, 5=fatal). Relatedness to study drug was assessed by the investigator (Yes/No). Participants with multiple occurrences of an adverse event within a category are counted once within the category.

  • Laboratory Abnormalities >/= Grade 3 [ Time Frame: Up to approximately 3 years ]
    Counts of study participants with post-baseline laboratory abnormalities of Grade 3 or greater per NCI CTCAE version 4.03. Participants with multiple occurrences of a laboratory abnormality within a category are counted once in that category

  • Brentuximab Vedotin Antibody-Drug Conjugate (ADC) Concentration at End of Infusion (Ceoi) [ Time Frame: Up to approximately 3 years ]
  • Brentuximab Vedotin Antibody-Drug Conjugate (ADC) Trough Concentration (Ctrough) [ Time Frame: Up to approximately 3 years ]
  • Maximum Concentration (Cmax) of Brentuximab Vedotin Monomethyl Auristatin E (MMAE) [ Time Frame: Up to approximately 3 years ]
  • Brentuximab Vedotin Monomethyl Auristatin E (MMAE) Trough Concentration (Ctrough) [ Time Frame: Up to approximately 3 years ]
  • Incidence of Anti-therapeutic Antibodies (ATA) [ Time Frame: Up to approximately 3 years ]
    Counts of participants with post-baseline anti-brentuximab vedotin antibodies. Persistently positive is defined as confirmed ATA in more than 2 post-baseline samples and transiently positive is defined as confirmed ATA in 1 or 2 post-baseline samples.


Enrollment: 84
Study Start Date: October 2011
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Brentuximab vedotin 1.8 mg/kg
Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
Drug: brentuximab vedotin
1.8 mg/kg every 3 weeks by intravenous (IV) infusion
Other Name: Adcetris; SGN-35
Experimental: Brentuximab vedotin 2.4 mg/kg
Brentuximab vedotin 2.4 mg/kg every 3 weeks by IV infusion
Drug: brentuximab vedotin
2.4 mg/kg every 3 weeks by intravenous (IV) infusion
Other Name: Adcetris; SGN-35
Experimental: Brentuximab vedotin 1.2 mg/kg
Brentuximab vedotin 1.2 mg/kg weekly, 3 out of 4 weeks, by IV infusion
Drug: brentuximab vedotin
1.2 mg/kg weekly, 3 out of 4 weeks, by intravenous (IV) infusion
Other Name: Adcetris; SGN-35

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   6 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically-confirmed by central review CD30-positive nonlymphomatous malignancy
  • Have failed, refused, or have been deemed ineligible for standard therapy
  • Measurable disease
  • Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1 or a Karnofsky or Lansky Performance Status score greater than or equal to 70

Exclusion Criteria:

  • Primary diagnosis of lymphoma or central nervous system (CNS) malignancy
  • History of another primary invasive malignancy that has not been definitively treated or in remission for at least 3 years
  • Evidence of active cerebral/meningeal disease
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01461538


  Show 29 Study Locations
Sponsors and Collaborators
Seattle Genetics, Inc.
Investigators
Study Director: Neil Josephson, MD Seattle Genetics, Inc.
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Seattle Genetics, Inc.
ClinicalTrials.gov Identifier: NCT01461538     History of Changes
Other Study ID Numbers: SGN35-013
First Submitted: October 24, 2011
First Posted: October 28, 2011
Results First Submitted: December 18, 2015
Results First Posted: March 4, 2016
Last Update Posted: March 4, 2016
Last Verified: February 2016

Keywords provided by Seattle Genetics, Inc.:
Acute Lymphoid Leukemia
Myelodysplastic Syndrome
Acute Myeloid Leukemia
Solid Tumors
Anemia, Refractory, with Excess of Blasts
Antibodies, Monoclonal
Antibody-Drug Conjugate
Antigens, CD30
Drug Therapy
Hematologic Diseases
Immunotherapy
Monomethyl Auristatin E

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Anemia, Refractory, with Excess of Blasts
Anemia, Refractory
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Anemia
Hematologic Diseases
Myelodysplastic Syndromes
Bone Marrow Diseases
Antibodies
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs